Study Results Indicate Rotator Cuff Function and Pain Improve with Use of InSpace

By Julie A. Vetalice

Study results demonstrated improved function and pain in 39 shoulder procedures employing the InSpace™ procedure for the surgical treatment of massive rotator cuff tears.

OrthoSpace’s InSpace biodegradable balloon spacer is placed arthroscopically in the subacromial space during a ten-minute procedure.

The data, published in Arthroscopy, found that range of motion was significantly increased for all patients in anterior elevation, abduction and external rotation. The mean Constant score, measuring pain, activity level and function, improved from 40 at baseline, when adjusted for age and gender, to 59 at one year. Patients involved in this study had one to three years of follow-up at the time of analysis.

InSpace is CE Marked in Europe and Israel. The system is investigational in the U.S. and Canada, where it is being evaluated in a prospective, single-blinded, multi-center, randomized, controlled study of 184 patients.

In 4Q16, OrthoSpace closed a $7MM equity financing round to support its U.S. Investigational Device Exemption study. Investors include HealthpointCapital, Smith & Nephew, TriVentures and Johnson & Johnson Innovation.

Source: OrthoSpace, ORTHOWORLD Inc.

Product Labels: Traditional Soft Tissue Repair

Tags: Trial/Study